A leading biopharmaceutical company focused on developing treatments for debilitating diseases is looking to hire a talented Associate Director of Chemical Development to join their growing team. The individual act as an individual contributor to mange the development of chemical processes for drug substances.
Responsibilities
- Manage and mentor process chemists internally and at contract manufacturers (CMOs)
- Manage development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs
- Develop target drug substance profiles and specifications, set goals and maintain timelines for CMO manufacturing activities
- Ensure quality, economics, and adequate supply chain security for drug substances
- Identify and facilitate purchase of custom raw materials and supplies needed for drug substance manufacturing under tight time constraints
- Develop and maintain good relationships and contracts with CMOs
- Visit, evaluate and audit contract sites for GMP manufacturing activities
- Work cross functionally with CMC analytical team and formulations team, QA and Regulatory teams
- Work collaboratively with partners for all drug substance related activities
- Compile documentation and draft CMC sections for regulatory submissions
- Support interdisciplinary working teams with recommendations, advice and action plans for drug substance related issues
- Represent the drug substance team in cross-functional working teams, and communicate drug substance related issues and information to groups within the company
Qualifications
- D. in Chemistry, Organic Chemistry, Chemical Engineering or related field
- Strong understanding of small molecules, preferred experience with oral solid dosage forms
- Direct experience with management of CMOs and CROs
- In depth knowledge of cGMP regulations and compliance
- Experience with regulatory filings (IND, NDA) strongly preferred
- Good understanding and knowledge of analytical methods and related issues
- Ability to travel domestically and internationally
If Interested please apply below!
